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Last update 23 Jan 2025

Calcitriol

Last update 23 Jan 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(1S,3R,5Z,7E)-9,10-secocholesta-5,7,10-triene-1,3,25-triol, (1α,3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol, (5Z,7E)-(1S,3R)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol

+ [24]

Target

VDR

Mechanism

VDR agonists(Vitamin D receptor agonists)

Therapeutic Areas

Immune System DiseasesEndocrinology and Metabolic DiseaseSkin and Musculoskeletal Diseases+ [3]

Active Indication

Plaque psoriasisGlucocorticoid-induced osteoporosisHypocalcemia+ [10]

Inactive Indication

Advanced cancerAdvanced Lung Non-Small Cell CarcinomaCastration-Resistant Prostatic Cancer+ [5]

Originator Organization

Validus Capital Pte Ltd.

Active Organization

Roche Pharma AG

Zhejiang Cheng Yi Pharmaceutical Co., Ltd.

SS Pharmaceuticals

+ [6]

Inactive Organization

Novacea, Inc.Galderma Research & Development SNCTeva GTC

Drug Highest PhaseApproved

First Approval Date

US (17 Aug 1978),

Hyperparathyroidism, SecondaryKidney Failure, Chronic

Regulation-

Structure/Sequence

Molecular FormulaC27H44O3

InChIKeyGMRQFYUYWCNGIN-NKMMMXOESA-N

CAS Registry32222-06-3

178

Clinical Trials associated with Calcitriol

CTR20243049

/ CompletedNot Applicable

骨化三醇软胶囊在健康人体空腹/餐后状态下的生物等效性试验

[Translation] Bioequivalence study of calcitriol soft capsules in healthy volunteers under fasting/fed conditions

主要研究目的：本研究以珠海健福制药有限公司持证的骨化三醇软胶囊（规格：0.25μg）为受试制剂，Atnahs Pharma UK Limited 持证的骨化三醇胶丸（商品名：罗盖全®，规格：0.25μg）为参比制剂，进行空腹/餐后状态下人体生物等效性试验，评价受试制剂和参比制剂在健康受试者体内的生物等效性。次要研究目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main research purpose: This study uses the calcitriol soft capsules (specification: 0.25μg) certified by Zhuhai Jianfu Pharmaceutical Co., Ltd. as the test preparation and the calcitriol capsules (trade name: Luogaiquan®, specification: 0.25μg) certified by Atnahs Pharma UK Limited as the reference preparation to conduct a human bioequivalence test under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects. Secondary research purpose: Observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date14 Sep 2024

Sponsor / Collaborator

Zhuhai Jianfu Pharmaceutical Co., Ltd.

CTR20242334

/ CompletedNot Applicable

骨化三醇胶丸在中国健康受试者中的一项随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉设计的生物等效性试验

[Translation] A randomized, open-label, single-dose, fasting and fed, two-formulation, two-sequence, two-period crossover bioequivalence study of calcitriol softgels in healthy Chinese subjects

主要研究目的研究空腹和餐后状态下单次口服骨化三醇胶丸（规格：0.25μg，大连美创药业有限公司）与参比制剂（规格：0.25μg，罗盖全®；持证商：Roche Pharma (Schweiz) AG）后骨化三醇在中国健康受试者体内的药代动力学（PK）特征，评价空腹和餐后状态下口服两种制剂的生物等效性。次要研究目的评价中国健康受试者空腹和餐后状态下，单次口服受试制剂骨化三醇胶丸和参比制剂骨化三醇胶丸后的安全性。

[Translation]

Main study objectives To study the pharmacokinetic (PK) characteristics of calcitriol in healthy Chinese subjects after a single oral administration of calcitriol capsules (specification: 0.25μg, Dalian Meichuang Pharmaceutical Co., Ltd.) and reference preparation (specification: 0.25μg, Rogaquan®; licensee: Roche Pharma (Schweiz) AG) in fasting and fed states, and to evaluate the bioequivalence of the two preparations in fasting and fed states. Secondary study objectives To evaluate the safety of the test preparation calcitriol capsules and reference preparation calcitriol capsules in healthy Chinese subjects after a single oral administration in fasting and fed states.

Start Date12 Jul 2024

Sponsor / Collaborator

Dalian Meichuang Pharmacy Co., Ltd.

CTR20240267

/ CompletedNot Applicable

骨化三醇胶丸在中国健康受试者中空腹和餐后状态下的随机、开放、两序列、两周期交叉设计生物等效性试验

[Translation] A randomized, open-label, two-sequence, two-period crossover bioequivalence study of calcitriol softgels in Chinese healthy subjects under fasting and fed conditions

主要研究目的研究空腹和餐后状态下单次口服骨化三醇胶丸（规格：0.25μg，山东简道制药有限公司）与参比制剂（规格：0.25μg，罗盖全®；持证商：Roche Pharma (Schweiz) AG）后骨化三醇在中国健康受试者体内的药代动力学（PK）特征，评价空腹和餐后状态下口服两种制剂的生物等效性。次要研究目的评价中国健康受试者空腹和餐后状态下，单次口服受试制剂骨化三醇胶丸和参比制剂骨化三醇胶丸后的安全性。

[Translation]

Main study objectives To study the pharmacokinetic (PK) characteristics of calcitriol in healthy Chinese subjects after a single oral administration of calcitriol capsules (specification: 0.25μg, Shandong Jiandao Pharmaceutical Co., Ltd.) and reference preparation (specification: 0.25μg, Rogaquan®; licensee: Roche Pharma (Schweiz) AG) in fasting and fed states, and to evaluate the bioequivalence of the two preparations in fasting and fed states. Secondary study objectives To evaluate the safety of the test preparation calcitriol capsules and reference preparation calcitriol capsules in healthy Chinese subjects after a single oral administration in fasting and fed states.

Start Date20 May 2024

Sponsor / Collaborator

Shandong Jiandao Pharmaceutical Co., Ltd.

100 Clinical Results associated with Calcitriol

100 Translational Medicine associated with Calcitriol

100 Patents (Medical) associated with Calcitriol

11,653

Literatures (Medical) associated with Calcitriol

01 Dec 2025·Molecular Biology Reports

Sirtuin 1 mediates the pro-survival effects of vitamin D in angiotensin II-induced hypertrophy of H9c2 cardiomyoblasts

Article

Author: Safari, Fatemeh ; Maroofi, Abdulbaset ; Astani, Akram ; Sarebanhassanabadi, Mohammadtaghi ; Hekmatimoghaddam, Seyedhossein

BACKGROUNDThe role of 1,25-dihydroxyvitamin-D3 (VitD) and sirtuin-1 (SIRT1) in mitigating pathological cardiac remodeling is well recognized. However, the potential for SIRT1 to mediate the inhibitory effects of VitD on angiotensin II (Ang II) -induced hypertrophy in H9c2 cardiomyoblasts remains unclear.METHODSH9c2 cardiomyoblasts were exposed to Ang II or a combination of VitD and Ang II, both in the absence and presence of SIRT1-specific siRNA. In each cell group, cell viability, hypertrophy, and redox state were evaluated using relevant techniques.RESULTSIn H9c2 cells transfected with SIRT1 siRNA, VitD failed to significantly counteract the Ang II-induced perturbations, which included a reduction in cell viability, decreased CAT and SOD activity/mRNA levels, diminished MnSOD mRNA levels, and increased MDA content. Conversely, VitD significantly inhibited Ang II-induced hypertrophy in H9c2 cells by reducing cell size and lowering ANP and BNP mRNA levels, regardless of SIRT1 status. Notably, neither Ang II nor VitD altered the expression of SIRT1 mRNA or protein in H9c2 cells.CONCLUSIONSIRT1 serves as an important regulator of pro-survival, but not anti-hypertrophic functions of VitD in hypertrophied cardiomyoblasts. Indeed, the absence of SIRT1 jeopardizes the capabilities of VitD to confer its pro-survival activity in H9c2 cells. Therefore, SIRT1-centered activating compounds may augment the protective effects of VitD, providing a promising therapeutic strategy to reduce the risk of cardiac hypertrophy and heart failure.

01 Mar 2025·Enzyme and Microbial Technology

Identification of a bacteria P450 enzyme from B. megaterium H-1 with vitamin D3 C-25 hydroxylation capabilities

Article

Author: Xu, Zhenghong ; Shi, Jingsong ; He, Yulin ; He, Fan ; Li, Hui ; Zhou, Jingyi ; Hou, Yina ; Zhang, Xiaomei

Calcidiol (25(OH)VD₃) and calcitriol (1α,25(OH)₂VD₃) are active vitamin D₃ with high medicinal value, which can maintain calcium and phosphorus balance and treat vitamin D deficiency. Microbial synthesis is an important method to produce high-value-added compounds. It can produce active vitamin D₃ through the hydroxylation reaction of P450, which can reduce the traditional chemical synthesis steps, and greatly improve the production efficiency and economic benefits. In this work, Bacillus megaterium H-1 was screened for its ability to produce 25(OH)VD₃ and 1α,25(OH)₂VD₃ from vitamin D₃. A new highly inducible vitamin D₃ hydroxylase CYP109E1-H was identified from B. megaterium H-1 through searching for transcripts with cytochrome P450 structural domains, combining the transcriptome sequencing with functional expression in Bacillus subtilis WB600. Biotransformation in recombinant B. subtilis confirmed that CYP109E1-H has C-25 hydroxylase activity towards vitamin D₃. CYP109E1-H is a natural mutant of CYP109E1 with greater stereoselectivity and it is a new vitamin D₃ mono-hydroxylase. The cloning and characterization of the CYP109E1-H gene provide useful information on the structural basis for improving the regional and stereoselectivity of the CYP109E gene.

01 Feb 2025·Journal of Surgical Research

A Postanesthesia Care Unit Parathyroid Hormone–Based Protocol for Managing Postthyroidectomy Hypocalcemia

Article

Author: Chen, Herbert ; Gillis, Andrea ; Song, Zhixing ; Wang, Rongzhi ; Allahwasaya, Ashba ; Wu, Christopher ; Fazendin, Jessica ; Lindeman, Brenessa

INTRODUCTIONHypocalcemia occurs in 20%-40% of total thyroidectomy cases, traditionally requires 1-2 ds of hospitalization for management. This study examines the extent of hypocalcemia following a postanesthesia care unit (PACU) parathyroid hormone (PTH)-based protocol after outpatient thyroidectomy.METHODSPatients who underwent total or completion thyroidectomy for non-Graves' disease at a single institution between December 2015 and September 2023 were included. Postoperative calcium and calcitriol supplementation followed a standardized protocol based on PACU PTH levels (<2, 2-9, 10-19, or >20 pg/mL), with higher doses given to patients with lower PACU PTH levels. Clinical outcomes including hypocalcemia were assessed.RESULTSOf the 250 patients included, the majority were female (77%) and White (69%), with a mean age of 47 ± 19 ys. The percentages of patients in the <2, 2-9, 10-19, and >20 PACU PTH groups were 4.4%, 20.0%, 20.8%, and 54.8%, respectively. A total of 61 (24.4%) patients experienced symptomatic hypocalcemia, with the highest incidence (81.8%) in the <2 group and the lowest (5.1%) in the >20 group. By 2 wks postsurgery, 6% had low serum calcium (<8.4 mg/dL), and 3.6% had persistent hypocalcemia symptoms. All patients resolved their symptoms at the last follow-up. There were 17 (6.8%) phone consultations and 3 (1.2%) emergency department visits due to hypocalcemia concerns. The readmission rate was 3.6%, with hypocalcemia causing only one case (0.4%).CONCLUSIONSUsing our PACU PTH protocol for outpatient total thyroidectomy is associated with a relatively low incidence of hypocalcemia requiring emergency department visits or readmission.

News (Medical) associated with Calcitriol

19 Sep 2024

·www.prnewswire.com

Kyowa Kirin to Present New Research Spotlighting Global Efforts to Advance Science and Patient Care in X-linked Hypophosphatemia at ASBMR Annual Meeting

One oral presentation and nine posters will shed light on real-world experiences of people living with XLH and the impact of burosumab treatment TOKYO, Sept. 19, 2024 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151) will share new research that enhances understanding about the use of burosumab in real-world clinical practice as well as the burden of those living with X-linked hypophosphatemia (XLH), a rare genetic metabolic bone disease. The findings will be presented at the American Society for Bone and Mineral Research (ASBMR) 2024 annual meeting, which takes place September 27-30 in Toronto. The oral presentation of "Patient reported outcomes (PRO) from a real-world study of burosumab treatment in adults with X-linked hypophosphatemia in the UK" will be made by Judith Bubbear, MD, Royal National Orthopaedic Hospital (UK) on Saturday, September 28, 11:30 am EDT (Presentation #1022). "As we learn more about XLH and how it impacts people's lives, real-world evidence can provide much-needed insight into potential strategies for managing this debilitating disease," said Angela Williams, PhD, Vice President and Global Head of Health Economics and Outcomes Research at Kyowa Kirin. "The breadth of our ASBMR data reflects our continued focus on advancing the science and understanding of XLH and improving the lives of people living with XLH." ASBMR XLH poster presentations: Real-world impact of burosumab treatment in people living with XLH: "Effectiveness of burosumab versus conventional therapy in adults with X-linked hypophosphatemia in a real-world setting from the XLH Disease Monitoring Program" (Poster#SAT-430) Lead author: Pablo Florenzano, MD, Pontificia Universidad Católica de Chile Poster Session I: Saturday, September 28, 2:15 – 3:45 pm EDT "Biochemical measurements according to age group in burosumab-treated patients with X-linked hypophosphatemia (XLH) in a real-world setting: an analysis of the XLH Disease Monitoring Program" (Poster #Fri-424, #Sun-424) Lead author: Leanne M. Ward, MD, Children's Hospital of Eastern Ontario Welcome Reception/Plenary Poster Session: Friday, Sept. 27, 5:30 – 7:30 pm EDT Poster Session II; Sunday, Sept. 29, 2:15 – 3:45 pm EDT "Symptoms experienced by adolescents living with X-linked hypophosphatemia at the end of skeletal growth (EOSG) treated with burosumab—a mixed methods analysis" (Poster #SAT-445) Lead author: Vrinda Saraff, MD, Birmingham Women's and Children's Hospital (UK) Poster Session I: Saturday, Sept. 28, 2:15 – 3:45 pm EDT "Efficacy and safety of burosumab in adult Chinese patients with X-linked hypophosphatemic rickets/osteomalacia (XLH): an open-label, multi-center, single-cohort, post-marketing phase IV study" (Poster#SUN-119) Lead author: Wei Liu, MD, Peking Union Medical College Hospital Poster Session II: Sunday, Sept. 29, 2:15 – 3:45 pm EDT "Efficacy and safety of burosumab in pediatric Chinese patients with X-linked hypophosphatemic rickets/osteomalacia (XLH): an open-label, multi-center, single-cohort, post-marketing phase IV study" (Poster#SAT-121) Lead author: Xiaoping Luo, MD, Tongji Medical College, Huazhong University of Science and Technology Poster Session I: Saturday, Sept. 28, 2:15 – 3:45 pm EDT XLH burden on multiple aspects of patients' lives: "Association between pain medication use and patient-reported outcomes in adults with X-linked hypophosphatemia: an exploratory analysis of a phase 3 study" (Poster #Sat-025) Lead author: Angela Williams, PhD, Kyowa Kirin International Poster Session I: Saturday, Sept. 28, 2:15 – 3:45 pm EDT "Individuals with hereditary hypophosphatemia are not prone to early death despite significant earlier development of co-morbidities: a retrospective Danish register study" (Poster #Sun-024) Lead author: Signe Sparre Beck-Nielsen, MD, PhD, Aarhus University Hospital (Denmark) Poster Session II: Sunday, Sept. 29, 2:15 – 3:45 pm EDT "X-linked Hypophosphatemia Community Impact Survey: psychosocial health, symptoms, and self-care" (Poster #SAT-LB 543) Lead author: Jill Simmons, MD, Vanderbilt University Medical Center Late Breaking Poster Session I: Saturday, Sept. 28, 2:15 – 3:45 pm EDT Bridging evidence gaps to improve clinical decision-making in XLH: "Advancing Patient Evidence in XLH (APEX): rational and design of real-world XLH global data unification program" (Poster #SAT-427) Lead author: Maria Luisa Brandi, MD, PhD, FIRMO Foundation, Florence, Italy and the University Vita-Salute San Raffaele, Milan, Italy Poster Session I: Saturday, Sep 28, 2:15-3:45 pm EDT About X-linked hypophosphatemia X-linked hypophosphatemia is a rare, lifelong, genetic disease that can impact the bones and muscles in both children and adults. In individuals with XLH, the body doesn't hold on to enough phosphorus, which is an essential mineral for bone health. This is due to the production of excess fibroblast growth factor 23 (FGF23), causing the body to release too much phosphorus through the urine. When phosphorus levels are too low (hypophosphatemia), it can cause the softening and weakening of growing bones in children (rickets) and of mature bones in adults (osteomalacia). In children, XLH typically appears as bowed legs or knock knees. Over time, bone weakening can also lead to bone abnormalities in the legs, delayed growth, and short stature. In adults, XLH may cause osteomalacia, fractures and pseudo-fractures, and hypophosphatemia. About CRYSVITA® (burosumab-twza) Injection CRYSVITA is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, which binds to and inhibits the biological activity of FGF23, the underlying cause of hypophosphatemia in XLH. By blocking FGF23, CRYSVITA helps to restore phosphorus reabsorption in the kidneys and increase the production of active vitamin D, which enhances intestinal absorption of phosphate and calcium. U.S. CRYSVITA Indication CRYSVITA is a fibroblast growth factor (FGF23) blocking antibody indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. Important Safety Information CONTRAINDICATIONS CRYSVITA is contraindicated: In concomitant use with oral phosphate and/or active vitamin D analogs (e.g., calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia. When serum phosphorus is within or above the normal range for age. In patients with severe renal impairment or end stage renal disease because these conditions are associated with abnormal mineral metabolism. WARNINGS AND PRECAUTIONS Hypersensitivity Hypersensitivity reactions (e.g., rash, urticaria) have been reported in patients with CRYSVITA. Discontinue CRYSVITA if serious hypersensitivity reactions occur and initiate appropriate medical treatment. Hyperphosphatemia and Risk of Nephrocalcinosis Increases in serum phosphorus to above the upper limit of normal may be associated with an increased risk of nephrocalcinosis. For patients already taking CRYSVITA, dose interruption and/or dose reduction may be required based on a patient's serum phosphorus levels. Injection Site Reactions Administration of CRYSVITA may result in local injection site reactions. Discontinue CRYSVITA if severe injection site reactions occur and administer appropriate medical treatment. ADVERSE REACTIONS Pediatric Patients Adverse reactions reported in 10% or more of CRYSVITA-treated pediatric XLH patients across three studies are: pyrexia (55%, 44%, and 62%), injection site reaction (52%, 67%, and 23%), cough (52%), vomiting (41%, 48%, and 46%), pain in extremity (38%, 46%, and 23%), headache (34% and 73%), tooth abscess (34%, 15%, and 23%), dental caries (31%), diarrhea (24%), vitamin D decreased (24%, 37%, and 15%), toothache (23% and 15%), constipation (17%), myalgia (17%), rash (14% and 27%), dizziness (15%), and nausea (10%). Postmarketing experience reported in CRYSVITA-treated pediatric XLH patients: blood phosphorus increased. Adult Patients Adverse reactions reported in more than 5% of CRYSVITA-treated adult XLH patients and in at least 2 patients more than placebo in one study are: back pain (15%), headache (13%), tooth infection (13%), restless legs syndrome (12%), vitamin D decreased (12%), dizziness (10%), constipation (9%), muscle spasms (7%), and blood phosphorus increased (6%). Spinal stenosis is prevalent in adults with XLH, and spinal cord compression has been reported. It is unknown if CRYSVITA therapy exacerbates spinal stenosis or spinal cord compression. USE IN SPECIFIC POPULATIONS There are no available data on CRYSVITA use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Serum phosphorus levels should be monitored throughout pregnancy. Report pregnancies to the Kyowa Kirin, Inc. Adverse Event reporting line at 1-844-768-3544. There is no information regarding the presence of CRYSVITA in human milk or the effects of CRYSVITA on milk production or the breastfed infant. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CRYSVITA and any potential adverse effects on the breastfed infant from CRYSVITA or from the underlying maternal condition. PATIENT COUNSELING INFORMATION Advise patients not to use any oral phosphate and/or active vitamin D analog products. Instruct patients to contact their physician if hypersensitivity reactions, injection site reactions, and restless legs syndrome induction or worsening of symptoms occur. You may report side effects to the FDA at (800) FDA-1088 or . You may also report side effects to Kyowa Kirin, Inc. at 1-844-768-3544. For important risk and use information, please see the full Prescribing Information for CRYSVITA. About Kyowa Kirin Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato oncology, and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across the globe. Learn more about Kyowa Kirin at: kyowakirin.com. COR-US-CRY-0049 September 2024 SOURCE Kyowa Kirin WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical Result

13 May 2024

·www.globenewswire.com

Entera Bio to Present Phase 1 Data from First-in-Class, PTH(1-34) Peptide Tablets (EB612) for the Treatment of Hypoparathyroidism at ENDO 2024

JERUSALEM, May 13, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and small therapeutic proteins, today announced that it has been selected to present data for its investigational program EB612 at the Endocrine Society ENDO 2024 Annual Meeting which will be held on June 1-4, 2024 in Boston, Massachusetts. The EB612 program is being developed by Entera to provide the first oral PTH(1-34) tablet peptide replacement therapy for patients suffering from hypoparathyroidism. Hypoparathyroidism is characterized by deficient PTH production, hypocalcemia and hyperphosphatemia. Standard treatments include several daily administrations of high dose oral calcium supplements and calcitriol (or analogs), which are often associated with ectopic calcification, including nephrocalcinosis and renal failure. Late stage investigational PTH replacement treatments include TransCon PTH (palopegteriparatide) by Ascendis Pharma A/S and eneboparatide (AZP-3601) by Amolyt Pharma (pending acquisition by AstraZeneca). Both these modalities require patients to administer injections every day. The data from this Phase 1 study include PK and early PD results from the application of a new generation of Entera’s N-Tab™ technology platform with an unmodified PTH(1-34) peptide. One of the objectives of this study was to test the new platform’s ability to reduce the frequency of daily administration of EB612. Entera previously published positive Phase 2a study results in 19 hypoparathyroid patients using a QID regimen (Fraser, JBMR 2021). Abstract Title: Phase 1 Study Results Of EB612, A First-in-Class Oral PTH(1-34) Analog For The Treatment Of Hypoparathyroidism Presentation Number: SAT-758 Presentation Type: Late-Breaking Poster Presentations: Day 1 Session: Poster Session P106 Session Date/Time: Saturday, June 1, 2024, 12:15 pm – 1:45 pm The abstract can be found on the ENDO 2024 website: https://www.abstractsonline.com/pp8/#!/11016/presentation/9825 About Entera Bio Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab™) and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram. Cautionary Statement Regarding Forward Looking Statements Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Phase 2Phase 1Clinical ResultAcquisitionPhase 3

14 Mar 2024

·www.prnewswire.com

Psoriasis in America - Insights into Psoriasis Patient Demographics, Quality of Life, Information-seeking Behaviors, HCP Engagement and Treatment Experiences

DUBLIN, March 14, 2024 /PRNewswire/ -- The "Psoriasis in America 2023: Understanding the Psoriasis Patient Experience" report has been added to ResearchAndMarkets.com's offering. Approximately 7.5 million people in the United States have psoriasis. This Psoriasis in America report provides a comprehensive look at life for those living with psoriasis. Using detailed quantitative data, it gives a full picture of the psoriasis patient experience - from symptoms to treatment to HCP relationships to quality of life - so you can make informed, strategic decisions, identify opportunities, and understand potential challenges. The report offers an in-depth look at the psoriasis patient experience. This large-scale, patient-reported data leverages vital quantitative insights essential to understanding key touchpoints in the psoriasis patient journey, including condition management, HCP engagement, quality of life, treatment experience and satisfaction, and much more. This report lifts the curtain on life with psoriasis, giving stakeholders an actionable look at the behaviors, attitudes, perceptions, needs, and experiences of people living with the condition. Data can be used to inform strategic decisions, including product communications, competitive assessments, concept development, landscape analyses, patient journey overlays, and forecasting inputs. This report also addresses important questions that stakeholders may not even know to ask while offering valuable insights into must-have patient-reported data points not available anywhere else. Add-on custom data analysis opportunities are also available for an additional cost - please see the report following purchase for more information. The analyst reaches millions of people through its portfolio of 45+ condition-specific online health communities - including PlaquePsoriasis.com - to provide information, connection, and support to patients and caregivers in the U.S. This report includes a deep-dive into: Psoriasis patient demographics Age, gender, ethnicity, marital status, children, employment status, income, location, insurance, and other health conditions Impact of psoriasis on quality of life Severity, impact on quality of life, symptoms experienced, and what patients wish others better understood Information-seeking behaviors Information sources used, plus topics of interest HCP engagement Primary HCP seen for condition, satisfaction with HCP, and discussion about brands aware of/not used Psoriasis treatment awareness and experiences Aided awareness of specific treatments, treatment experience, satisfaction with current treatments, perceived control with current treatment plan, and interest/participation in clinical trials Key questions answered in this report: To what extent do people say psoriasis impacts their overall quality of life? What's the average number of flares in the past year? What do patients wish others understood about psoriasis? What percentage of patients see a specialist for psoriasis treatment? What treatments have the highest aided brand awareness among patients? What percentage of patients use a biologic? How many patients feel their psoriasis is well-controlled on their current treatment plan? What percentage of patients are likely to switch or add new treatments in the next six months? What medications have patients discussed with their HCP? What are the top online resources people with psoriasis use to find information? What kinds of content and information do patients search for? What percentage of patients search for information on treatment options? Methodology Psoriasis in America consists of: A 20-minute online quantitative survey, covering demographics, comorbidities, quality of life/impact, HCP interactions, as well as treatment awareness, experiences, and discussions Qualitative patient insights from open-ended responses Additional details: Fielded: January 16, 2023 to April 14, 2023 Convenience sample of 490 respondents diagnosed with psoriasis Respondents are age 18+, living in the U.S., and are recruited from proprietary online health communities and recruiting partners Key Topics Covered: Respondent Demographics Research Highlights Condition Status and Quality of Life Severity and Exacerbations Symptoms Experienced Impact on Quality of Life Qualitative Patient Insights Information-Seeking Behaviors Resources Used to Manage Health Types of Content/Information Sought Treatment Awareness and Experiences Primary HCP Seen for Psoriasis Care Aided Brand Awareness of Treatments Treatment Usage Condition Control on Current Treatment and Clinical Trial Interest Treatment Discussions with HCP Appendix with All Data Charts and Distributions Brands and treatments mentioned in this report include: Topical corticosteroid (such as hydrocortisone) BRYHALIT (halobetasol propionate) lotion DesOwen (desonide) SERNIVOT (betamethasone dipropionate) SORILUXT Foam (calcipotriene) TACLONEX (calcipotriene and betamethasone) TAZORAC (tazarotene) VECTICAL (calcitriol) VTAMA (tapinarof) ZITHRANOLT-RR (anthralin) ZORYVET (roflumilast) Acitretin (SORIATANE) ARAVA (leflunomide) Azathioprine (such as IMURAN, AZASAN) Cyclosporine (such as Sandimmune, NEORAL, RESTASIS) Methotrexate (eg, Rheumatrex), also sometimes given as an injection OTEZLA (apremilast) PLAQUENIL (hydroxychloroquine) RINVOQ (upadacitinib) SOTYKTUT (deucravacitinib) Sulfasalazine (Azulfidine) XELJANZ/XELJANZ XR (tofacitinib citrate) AMJEVITAT (adalimumab-atto) Hide until launched in US AVSOLA (infliximab-axxq) CIMZIA (certolizumab) COSENTYX (secukinumab) CYLTEZO (adalimumab-adbm) Hide until launched in US ENBREL (etanercept) ERELZIT (etanercept-szzs) Hide until launched in US HULIO (adalimumab-fkjp) Hide until launched in US HUMIRA (adalimumab) HYRIMOZ (adalimumab-adaz) Hide until launched in US ILUMYAT (tildrakizumab-asmn) INFLECTRA (infliximab-dyyb) IXIFIT (infliximab-qbtx) Hide until launched in US ORENCIA (abatacept) REMICADE (infliximab) RENFLEXIST (infliximab-abda) SIMPONI (golimumab) SIMPONI ARIA (golimumab for infusion) SILIQT (brodalumab) SKYRIZI (risankizumab-rzaa) STELARA (ustekinumab) TALTZ (ixekizumab) TREMFYA (guselkumab) For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

100 Deals associated with Calcitriol

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KEGG	Wiki	ATC	Drug Bank
D00129	Calcitriol	D05AX03 A11CC04	DB00136

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Plaque psoriasis	US	Galderma Laboratories LP	23 Jan 2009
Glucocorticoid-induced osteoporosis	AU	Atnahs Pharma Australia Pty Ltd.	18 Mar 2003
Hypocalcemia	AU	Atnahs Pharma Australia Pty Ltd.	18 Mar 2003
Chronic Kidney Disease-Mineral and Bone Disorder	CN	Roche Pharma AG	17 Sep 1999
Osteoporosis, Postmenopausal	CN	Roche Pharma AG	17 Sep 1999
Bone Diseases, Metabolic	US	SS Pharmaceuticals	20 Nov 1998
Osteoporosis	JP	Chugai Pharmaceutical Co., Ltd.	11 Sep 1989
Vitamin D Deficiency	JP	Chugai Pharmaceutical Co., Ltd.	05 Nov 1985
Hyperparathyroidism, Secondary	US	SS Pharmaceuticals	17 Aug 1978
Kidney Failure, Chronic	US	SS Pharmaceuticals	17 Aug 1978

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoporosis	NDA/BLA	CN	Hainan Sihuan Pharmaceutical Co. Ltd.	11 Feb 2022
Osteoporosis	NDA/BLA	CN	Strides Pharma Science Ltd.	11 Feb 2022
Castration-Resistant Prostatic Cancer	Phase 2	HU	Novacea, Inc.	01 Jan 2006
Castration-Resistant Prostatic Cancer	Phase 2	SK	Novacea, Inc.	01 Jan 2006
Castration-Resistant Prostatic Cancer	Phase 2	US	Novacea, Inc.	01 Jan 2006
Castration-Resistant Prostatic Cancer	Phase 2	DE	Novacea, Inc.	01 Jan 2006
Castration-Resistant Prostatic Cancer	Phase 2	ME	Novacea, Inc.	01 Jan 2006
Castration-Resistant Prostatic Cancer	Phase 2	RO	Novacea, Inc.	01 Jan 2006
Castration-Resistant Prostatic Cancer	Phase 2	CZ	Novacea, Inc.	01 Jan 2006
Castration-Resistant Prostatic Cancer	Phase 2	CA	Novacea, Inc.	01 Jan 2006

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Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ENDO2024	Not Applicable	Hypoparathyroidism PTH mutation	-	Teriparatide 20 mcg SC daily	(rtbezybner) = wnsnymdxsx yrjycviluv (qkzuvyssij ) View more	Positive	01 Jun 2024
				Calcitriol and calcium carbonate	(rtbezybner) = sidnjazcfn yrjycviluv (qkzuvyssij ) View more
ENDO2024	Not Applicable	Renal Cell Carcinoma calcitriol \| intact parathyroid hormone (PTH) \| PTH-related protein (PTHrP) ... View more	-	Calcitriol-mediated hypercalcemia	mxhssasikj(cztisabaxa) = tchipseimt pcsebeitcl (frsdfuolea ) View more	-	01 Jun 2024
WCO_IOF_ESCEO2024	Not Applicable	-	61	Calcitriol 0.5 mcg	zwcwuhnyeq(rlugjduxar) = Hypercalcemia occurred in 39% and 3% in the calcitriol and placebo groups respectively egbdgktxxb (mlgxllnwgx )	Negative	11 Apr 2024
				Placebo
EHA2023	Not Applicable	Juvenile Myelomonocytic Leukemia	29	Tretinoin	bhvmrsnctm(okdlvvdpgy) = oqwaiejiyb cdhjpakbkj (inuevywufl )	-	08 Jun 2023
				Calcitriol	bhvmrsnctm(okdlvvdpgy) = zdrcgguvxf cdhjpakbkj (inuevywufl )
ESPE2022	Not Applicable	Familial Hypophosphatemic Rickets PHEX gene mutation	15	Burosumab	(lvmsypwhav) = reported in one patient fpdcromtif (zdgdbthiph ) View more	-	15 Sep 2022
				Conventional treatment (inorganic oral phosphate salts and calcitriol or alphacalcidol)
NCT00763555 (CTgov)	Phase 2	Plaque psoriasis	88	CD 2027 (Calcitriol 3 mcg/g Spray)	ysdfuxjlep(cqeqooiacn) = geubmmbjnx eyetrgthnh (veazzsdgma, pdzrlkusin - jeekneugjb) View more	-	23 Aug 2022
				Calcitriol Vehicle (Calcitriol Vehicle)	ysdfuxjlep(cqeqooiacn) = wlprkdkkgd eyetrgthnh (veazzsdgma, budwukzisf - wbncrjaqln) View more
MO803 (ERA2022)	Not Applicable	Hyperparathyroidism, Secondary	-	Paricalcitol	ungfrlyhqs(igjmxkomgy) = rewcwkbzfr mwnstrdnis (eaajxjnavl )	Positive	03 May 2022
				Calcitriol	ungfrlyhqs(igjmxkomgy) = fhlamptbqi mwnstrdnis (eaajxjnavl )
NCT04286529 (CTgov)	Phase 1	Prediabetic State	17	Calcitriol capsules (Men-Calcitriol)	fzmmttfkzz(drizsvcdxh) = lpkstzlyfk ffrcjtzdda (lofukqzley, dxnsmpvmfk - wmmsyvkmyq) View more	-	18 Apr 2022
				Calcitriol capsules (Premenopausal Women-Calcitriol)	fzmmttfkzz(drizsvcdxh) = aziszuhwae ffrcjtzdda (lofukqzley, itrfywgnse - jwdtplkniu) View more
NCT02962102 (ACTIVATE-AKI, CTgov)	Phase 2	Critical Illness \| Acute Kidney Injury	150	Calcifediol (Calcifediol)	zcxkejgbra(olrxuivwti) = khwchzcnqa axzbyoougu (zyuuechsru, lqataavvga - zipaldfoui) View more	-	03 Feb 2022
				Calcitriol (Calcitriol)	zcxkejgbra(olrxuivwti) = taftolllrw axzbyoougu (zyuuechsru, lctchtpctl - pvcxmjfjba) View more
ASN2021	Not Applicable	FGF-23 \| 1 α -hydroxylase	-	Doxercalciferol 1 mcg IV three times a week	gtgnezpiwd(gazcppozfm) = kxwjrxbuhe pwnerkmcgq (etewnkwnlb ) View more	Negative	27 Oct 2021
				Doxercalciferol 20 mcg three times a week	gtgnezpiwd(gazcppozfm) = yilpfpwwfb pwnerkmcgq (etewnkwnlb ) View more

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